Job Summary
The Senior Hardware Engineer shall play a pivotal role in design, development, Testing of Electrophysiology (EP), Cardiovascular capital systems and Ablation Catheter products. This role involves collaborating with various stakeholders to draft design specifications, develop prototypes, create schematics, Testing, V&V and ensuring integrating the design into EP or Ablation procedures.
Key Responsibilities
- Draft System Requirements and Hardware functional requirements for Medical Device Systems, capital equipment, and accessories.
- Develop and Validate Prototypes and Proof-of-Concept models for system, sub-system, and critical components to support system characterization and make design decisions.
- Draft design documents, schematics, BOM Generation, PCB & Gerber Layout board design, and review, coordinating with vendor and CM for manufacturing.
- Perform System and Sub-system Testing, Troubleshooting, V&V, drafting test protocols, test execution, and report generation.
- Coordinate With Cross-Functional Teams, including System, Software, Mechanical, Quality and Regulatory team to ensure cohesive integration of design and release within overall Project.
Skill Requirements
- Bachelor’s or Master’s degree in electrical or electronics engineering, or a related technical STEM field.
- Minimum 3 years of NPD R&D design & development experience preferably in medical products life cycle design and development.
- Preferred experience in R&D Electrophysiology capital systems involving cardiovascular, heart recovery solutions, and ablation catheters using RF, IRE, PFA or similar technology.
- Knowledge in BOM, component engineering, schematics creation and layout review.
- Knowledge in microprocessor and microcontroller-based designs.
- Proficient in Testing, Troubleshooting, verification & validation, drafting test protocols, test execution, and report generation.
Knowledge in FDA class device, ISO 13485, IEC 60601 standards.